HypoxiaNCT02801162
Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard
A study testing conventional ABG analyser and Proxima 3® in people with Hypoxia and Hypercapnia, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative clinical data at various time points. Compare the methods associated with obtaining blood gas results using the Proxima 3® System device versus a conventional ABG analyse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia, Hypercapnia, Anaemia
- What is being tested?
- conventional ABG analyser and Proxima 3®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥18 years old
- Patients who have (or will have) an arterial line, which was (will be) inserted for clinical - need, will be considered for inclusion in this study
- Patients who give informed consent (or their personal/nominated consultee) to participate in the study
- Patients who are likely to have an arterial line for at least 6 hours.
Who cannot join
- Patients contraindicated for an arterial line
- Refusal of consent by a patient
- Not for use with patients with uncorrected hyperphosphataemia, hypocalcaemia or hypercalcaemia.
- The patient is considered to be unsuitable for the study by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Accuracy and Precision of the Proxima 3® (Sphere Medical) Arterial Blood Gas Analysis System in Comparison With the Reference Standard Hospital ABG in a Rapidly Changing Clinical Context
Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative clinical data at various time points. Compare the methods associated with obtaining blood gas results using the Proxima 3® System device versus a conventional ABG analyse. The aim of the investigator is to evaluate the precision and accuracy of the Proxima 3® ABG system parameters (pH, pCO2 pO2, hematocrit and potassium) in clinical practices with rapid changing context.
Read the detailed description
In this study the investigator will test the applicability of the Proxima 3® ABG system in a heterogeneous patient population consisting of patients scheduled for hybrid atrial fibrillation surgery, patients scheduled for heart valve surgery, complex cardiac surgery with deep cooling, spine surgery or patients with expected major blood loss. The investigator will compare the ABG values obtained with the traditional ABG measurement system of the hospital.
The availability of a disposable patient-dedicated blood gas analyser allows rapid, frequent measurement of blood gases in theatre without the loss of theatre staff. As well as facilitating measurement in the unstable patient, this approach opens up the possibility for more frequent measurement to identify patient deterioration before a crisis occurs.
The conventional laboratory ABG method uses sensor technology for pH, pCO2, pO2, sodium, potassium, calcium, glucose and lactate levels. It measures hemoglobin concentration via spectrophotometry methodology at a set wavelength of 467-672 nm. The blood gas laboratory uses ABL90 Flex (Radiometer®). The optical system is based on a 138-wavelength spectrophotometer with a measuring range of 467-672 nm. The spectrophotometer is connected via an optical fiber to a combined hemolyzer and measuring chamber.
- Conditions
- Hypoxia, Hypercapnia, Anaemia
- Being tested
- conventional ABG analyser, Proxima 3®
- Keywords
- arterial blood gas
- Medical subject headings
- Hypoxia, Hypercapnia, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional ABG analyserDevice
pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %
Proxima 3®Device
pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %
| Study group | Role | What they receive |
|---|---|---|
| Conventional ABG analyser | Active comparator | Not described Receives: Device: conventional ABG analyser; Device: Proxima 3® |
| Proxima 3® arterial blood gas | Experimental | Not described Receives: Device: conventional ABG analyser; Device: Proxima 3® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of accuracy and precision of the Proxima 3® for ABG
Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative clinical data at various time points
Measured: From intubation until extubation, max 1 day
Secondary outcomes (1)
Time to obtain an arterial blood gas
Time for obtaining arterial blood gas: prelevation time to result time
Measured: From intubation until extubation, max 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017
- Study completionApr 2017
Why it stopped: To much effort needed, high costs for an academic study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Umbrain, MD PhD, Principal investigator, Universitair Ziekenhuis BrusselJan Poelaert, MD, PhD, Study director, Universitair Ziekenhuis BrusselManuella Martin, Apr. Biol., Study chair, Universitair Ziekenhuis BrusselChristine Sneyers, Nurse, Principal investigator, Universitair Ziekenhuis BrusselGabriel Kotolácsi, MD, Principal investigator, Universitair Ziekenhuis BrusselPierre Matagne, Nurse, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801162
- Sponsor's protocol ID
- PROXIMA
- Status last verified
- Oct 2018
- First submitted
- 31 May 2016
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy and Precision of the Proxima 3® (Sphere Medical) Arterial Blood Gas Analysis System in Comparison With the Reference Standard Hospital ABG in a Rapidly Changing Clinical Context
- ClinicalTrials.gov ID
- NCT02801162
- Acronym / sponsor ID
- PROXIMA
- Conditions
- Hypoxia, Hypercapnia, Anaemia
- Keywords
- arterial blood gas
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: To much effort needed, high costs for an academic study
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative clinical data at various time points. Compare the methods associated with obtaining blood gas results using the Proxima 3® System device versus a conventional ABG analyse. The aim of the investigator is to evaluate the precision and accuracy of the Proxima 3® ABG system parameters (pH, pCO2 pO2, hematocrit and potassium) in clinical practices with rapid changing context.
Detailed description
In this study the investigator will test the applicability of the Proxima 3® ABG system in a heterogeneous patient population consisting of patients scheduled for hybrid atrial fibrillation surgery, patients scheduled for heart valve surgery, complex cardiac surgery with deep cooling, spine surgery or patients with expected major blood loss. The investigator will compare the ABG values obtained with the traditional ABG measurement system of the hospital.
The availability of a disposable patient-dedicated blood gas analyser allows rapid, frequent measurement of blood gases in theatre without the loss of theatre staff. As well as facilitating measurement in the unstable patient, this approach opens up the possibility for more frequent measurement to identify patient deterioration before a crisis occurs.
The conventional laboratory ABG method uses sensor technology for pH, pCO2, pO2, sodium, potassium, calcium, glucose and lactate levels. It measures hemoglobin concentration via spectrophotometry methodology at a set wavelength of 467-672 nm. The blood gas laboratory uses ABL90 Flex (Radiometer®). The optical system is based on a 138-wavelength spectrophotometer with a measuring range of 467-672 nm. The spectrophotometer is connected via an optical fiber to a combined hemolyzer and measuring chamber.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ABG analyser | Active comparator | Device: conventional ABG analyser, Device: Proxima 3® |
| Proxima 3® arterial blood gas | Experimental | Device: conventional ABG analyser, Device: Proxima 3® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients ≥18 years old
- Patients who have (or will have) an arterial line, which was (will be) inserted for clinical - need, will be considered for inclusion in this study
- Patients who give informed consent (or their personal/nominated consultee) to participate in the study
- Patients who are likely to have an arterial line for at least 6 hours.
Key exclusion criteria (4 listed)
- Patients contraindicated for an arterial line
- Refusal of consent by a patient
- Not for use with patients with uncorrected hyperphosphataemia, hypocalcaemia or hypercalcaemia.
- The patient is considered to be unsuitable for the study by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional ABG analyserpO2 mmHg, pH, pCO2 mmHg, Base excess, Hct % | Device | Conventional ABG analyser, Proxima 3® arterial blood gas |
| Proxima 3®pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct % | Device | Conventional ABG analyser, Proxima 3® arterial blood gas |
Primary outcome
Evaluation of accuracy and precision of the Proxima 3® for ABG
Time frame: From intubation until extubation, max 1 day
Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative clinical data at various time points
1 secondary outcome
Time to obtain an arterial blood gas
Time frame: From intubation until extubation, max 1 day
Results and safety
The study was stopped early (reason given: To much effort needed, high costs for an academic study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Umbrain, MD PhD principal investigator
Universitair Ziekenhuis Brussel
Jan Poelaert, MD, PhD study director
Universitair Ziekenhuis Brussel
Manuella Martin, Apr. Biol. study chair
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional ABG analyser and Proxima 3® in people with Hypoxia and Hypercapnia, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: To much effort needed, high costs for an academic study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of accuracy and precision of the Proxima 3® for ABG (time frame: From intubation until extubation, max 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.